The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer

Diabetes Mellitus Clinical Trial

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Official title:

The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716623
• Other study ID #: STUDY00001802
• Secondary ID: UL1TR000001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.

Description:

This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.

Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.

Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of non-muscle-invasive bladder cancer

• Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure

• Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening

Exclusion Criteria:

• Evidence of muscle-invasion or metastatic disease

• BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)

• Unable to complete the exercise regimen or deemed a fall risk

• Participating in a research study involving any form of treatment intervention

Related Conditions & MeSH terms

• Bladder Cancer
• Diabetes Mellitus
• Urinary Bladder Neoplasms

Intervention

Other:
• CR diet
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.

Behavioral:
• Exercise
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant compliance with study specific CR diet	Measure participant compliance with CR diet. Compliance will be measured through adherence to study diet. Study team members will regularly check in with participants to track weekly food data.	12 months
Secondary	Presence of Tumor M2-PK	Level of Tumor M2-PK will be assessed over the course the study.	12 months